Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study

A Supraglottic Instillation Device for Administration of Surfactant in Neonates- A Pilot Study

A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.

Study Overview

• Status: Suspended
• Conditions: Chronic Lung Disease; RDS of Prematurity; Surfactant Protein B Deficiency
• Intervention / Treatment: Combination product: surfactant airway device

Detailed Description

Surfactant therapy can be life-saving for newborn infants with respiratory distress due to surfactant insufficiency, also known as respiratory distress syndrome (RDS). All commercially available surfactants for clinical use are approved for administration through an endotracheal tube. Placement of an endotracheal tube, a procedure called intubation, is stressful for the infant and associated with significant adverse effects. The proposed supraglottic instillation device allows infants to benefit from surfactant therapy while avoiding the negative effects of intubation.

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women & Newborns
  • Florida
    • Saint Petersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital
  • New York
    • Buffalo, New York, United States, 14214
      • Sisters of Charity Hospital
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Jackson-Madison County General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Gestational age at the time of enrollment ≥ 24 0/7 weeks
• Weight at the time of enrollment 500- 5000 grams
• Age ≤ 24 hours old
• Require non-invasive respiratory support (i.e. continuous positive airway pressure, high flow nasal cannula or non-invasive ventilation)
• Require FiO2 ≤ 40%
• Clinical diagnosis of RDS

Exclusion Criteria:

• Prior surfactant administration
• Prior mechanical ventilation
• Major congenital anomaly
• Abnormality of the airway
• Respiratory distress secondary to an etiology other than RDS (suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
• Apgar score < 5 at 5 minutes of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Surfactant administered via supraglottic administration device; Patients in this group will have Calfactant at 3ml/kg administered via the supraglottic administration device.

Combination product: surfactant airway device; Infants who meet eligibility criteria and have a signed consent form by their parent or guardian will be enrolled in the study. Once enrolled, the surfactant airway device placement and surfactant administration will occur as detailed in the protocol. The infant will be monitored. If the infant meets instillation failure criteria, the procedure will be repeated shortly after the initial procedure. A maximum of two (2) doses will be given during the initial procedure. If the infant meets re-dosing criteria, (s)he may receive up to two (2) additional doses through the surfactant airway device (initial procedure with 1-2 doses and up to two additional doses). If at any time the infant reaches treatment failure criteria, the infant would be intubated and receive a site-specific surfactant through an endotracheal tube. Study outcome data will be followed until discharge from the NICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Instillation failures	Instillation failure is defined as a lack of clinical response	First 10 minutes after surfactant instillation.
Treatment failure	"Treatment failure" defined as requiring intubation and liquid surfactant instillation with or without mechanical ventilation.	First 3 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response	Duration of oxygen therapy	3 days
Clinical response	duration of non-invasive respiratory therapy	3 days
Clinical response	number of rescue surfactant doses	3 days
Clinical response	incidence of pulmonary air leak	3 days
Clinical response	pulmonary hemorrhage	3 days
Clinical response	chronic lung disease	defined as need for oxygen at 36 weeks post menstrual age

Collaborators and Investigators

• Sponsor: ONY
• Investigators: Study Chair: Kari Roberts, MD, Kari Roberts, MD - University of Minnesota, Minneapolis, MN

Study record dates

Study Major Dates

• Study Start (Estimated): February 7, 2025
• Primary Completion (Estimated): December 12, 2025
• Study Completion (Estimated): March 12, 2026

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: RDS; Neonatal RDS; Surfactant Deficiency
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: ProVia-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes